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Health Condition(s) or Problem
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Chronic Non-cancer Pain; Opioid Induced Constipation
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Lay Summary
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For many patients taking opioids for pain relief one of the most distressing side effects is
constipation. Naloxone is effective in the reversal of the effects of opioids and is used
following opioid overdose. If naloxone is given by mouth it would relieve the effects of
constipation but as it goes into the blood stream very quickly, it would also reverse the
effects of the opioid and therefore stop the pain relief. The aim of this study is to
examine a slow release formulation of naloxone to see if is can reduce constipation without
reducing the pain relieving effects of the opioid.
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
- All subjects must give written informed consent
- Male or female subjects greater than 18 years of age
- Taking opioid full agonist therapy(oral or transdermal) for persistent non-cancer
pain, for at least 4 weeks prior to baseline visit
- Subjects with at least a 3 week history of OIC prior to baseline; where bowel
dysfunction is predominantly due to opioids and started following commencement of
opioid therapy
- Subjects with <3 SBMs a week and experiencing one or more bowel symptoms (incomplete
evacuation, straining, hard/small pellets) for 25% or more of bowel movements during
the screening period
- Subjects must be willing to discontinue all current laxative (constipation) therapy.
Bisacodyl will be provided and taken as required
Exclusion Criteria:
- Women of childbearing potential, unless surgically sterile or using adequate
contraception (either IUD, oral or depot contraceptive, or barrier plus spermicide).
Women using oral contraception must have started using it at least 2 months prior to
enrolment
- Women who are pregnant or breastfeeding
- Symptoms suggestive of non-opioid related bowel dysfunction (e.g. IBS - intermittent
constipation or diarrhoea) or have diarrhoea or loose stools in the 4 weeks prior to
baseline
- History of chronic constipation prior to commencing opioid therapy
- Gastrointestinal disorders known to affect bowel transit, or contribute to bowel
dysfunction (other than OIC)
- Chronic faecal incontinence
- Subjects who have a colostomy, ileostomy, or colectomy with ileorectal anastomosis
- Subjects with a history of neoplastic disease within 5 years (except for basal cell
carcinoma or non-metastatic squamous cell carcinoma of the skin)
- Subjects taking opioids for the management of drug addiction Subjects who do not meet
any of the following criteria regarding baseline medications. Analgesia (including
opioids and NSAIDs) should be stable throughout the trial.
- Any baseline analgesia must have been administered at a stable dose for a
minimum of 4 weeks. If non-opioid analgesia recently discontinued, must have
stopped at least 4 weeks prior to baseline
- Laxatives (outside that allowed by the protocol) are not permitted; these agents
must have been discontinued at the screening visit.
- Use of drugs known to affect gut transit time (other than opioids) are not
permitted (see Section 6.9 for exceptions)
- Use of mixed agonist/antagonist, or partial agonist opioids are not permitted
(e.g. buprenorphine, pentazocine, cyclazocine, nalbuphine, nalorphine)
- Experimental agents must have been discontinued at least 8 weeks prior to
screening, or for a period equivalent to 5 half-lives (t½) of the agent
(whichever is longer)
- Subjects with a history of clinically significant and/or persistent disorder
that, in the investigators opinion, may affect the clinical trial assessments
- Subjects with any laboratory tests considered clinically significant at
screening.
- Subjects not ambulatory i.e. bedridden or require use of a commode
- Subjects who will be unavailable for the duration of the trial, likely to be
non-compliant with the protocol, or who are felt to be unsuitable by the
Investigator for any other reason
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Who cannot enter the trial
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Inclusion Criteria:
- All subjects must give written informed consent
- Male or female subjects greater than 18 years of age
- Taking opioid full agonist therapy(oral or transdermal) for persistent non-cancer
pain, for at least 4 weeks prior to baseline visit
- Subjects with at least a 3 week history of OIC prior to baseline; where bowel
dysfunction is predominantly due to opioids and started following commencement of
opioid therapy
- Subjects with <3 SBMs a week and experiencing one or more bowel symptoms (incomplete
evacuation, straining, hard/small pellets) for 25% or more of bowel movements during
the screening period
- Subjects must be willing to discontinue all current laxative (constipation) therapy.
Bisacodyl will be provided and taken as required
Exclusion Criteria:
- Women of childbearing potential, unless surgically sterile or using adequate
contraception (either IUD, oral or depot contraceptive, or barrier plus spermicide).
Women using oral contraception must have started using it at least 2 months prior to
enrolment
- Women who are pregnant or breastfeeding
- Symptoms suggestive of non-opioid related bowel dysfunction (e.g. IBS - intermittent
constipation or diarrhoea) or have diarrhoea or loose stools in the 4 weeks prior to
baseline
- History of chronic constipation prior to commencing opioid therapy
- Gastrointestinal disorders known to affect bowel transit, or contribute to bowel
dysfunction (other than OIC)
- Chronic faecal incontinence
- Subjects who have a colostomy, ileostomy, or colectomy with ileorectal anastomosis
- Subjects with a history of neoplastic disease within 5 years (except for basal cell
carcinoma or non-metastatic squamous cell carcinoma of the skin)
- Subjects taking opioids for the management of drug addiction Subjects who do not meet
any of the following criteria regarding baseline medications. Analgesia (including
opioids and NSAIDs) should be stable throughout the trial.
- Any baseline analgesia must have been administered at a stable dose for a
minimum of 4 weeks. If non-opioid analgesia recently discontinued, must have
stopped at least 4 weeks prior to baseline
- Laxatives (outside that allowed by the protocol) are not permitted; these agents
must have been discontinued at the screening visit.
- Use of drugs known to affect gut transit time (other than opioids) are not
permitted (see Section 6.9 for exceptions)
- Use of mixed agonist/antagonist, or partial agonist opioids are not permitted
(e.g. buprenorphine, pentazocine, cyclazocine, nalbuphine, nalorphine)
- Experimental agents must have been discontinued at least 8 weeks prior to
screening, or for a period equivalent to 5 half-lives (t½) of the agent
(whichever is longer)
- Subjects with a history of clinically significant and/or persistent disorder
that, in the investigators opinion, may affect the clinical trial assessments
- Subjects with any laboratory tests considered clinically significant at
screening.
- Subjects not ambulatory i.e. bedridden or require use of a commode
- Subjects who will be unavailable for the duration of the trial, likely to be
non-compliant with the protocol, or who are felt to be unsuitable by the
Investigator for any other reason
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What will happen
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Drug; Naloxone SR 5 mg capsules; Nalone SR 5mg capsules; Drug; Placebo; Capsules with no active drug; Drug; Naloxone SR 10 mg capsules; Naloxone SR 10mg capsules; Drug; Naloxone SR 20mg capsules; Naloxone SR 20 mg capsules; Drug; Naloxone SR 2.5 mg capsules; Naloxone SR 2.5 mg capsules
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Primary aim
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To assess the safety and tolerability of multiple doses of Naloxone SR capsules in subjects taking opioid analgesics
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Secondary Aim
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Sorry, not currently available
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Completed
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Nation
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England
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Location
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Leeds, Norwich
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